Hikal’s API manufacturing site in Bengaluru completes 3rd successful US FDA inspection

Our Bureau, MumbaiWednesday, February 8, 2012, 16:00 Hrs  [IST]

Hikal Limited, a leading manufacturer of active ingredients, intermediates and regulated starting materials, has successfully completed its third US Food and Drug Administration (FDA) audit at its API manufacturing facility located at Jigani, Bengaluru.

The third site approval (June 2004, July 2008, August 2011) accorded by the US FDA will enable the company to continue to manufacture and supply a wide range of active pharmaceutical ingredients (APIs) from this facility to its customers in the US, European and Japanese markets.

Commenting on this achievement, Ashok Anand, president of Hikal’s pharmaceutical division said “This approval from the US FDA will give us the ability to ramp up our new products under validation and build on our strong position in our existing molecules.”

The inspection was carried out at the Jigani, Bangalore site over a period of five days.

“Compliance to current regulatory standards and guidelines is critical for Hikal and its customers. This approval is a true testimony to the high standards of quality, regulatory compliance and operating standards at our company. Our culture of building quality into all we do is continuously reinforced at all our sites and across all levels in the organization, ” said Sameer Hiremath, joint managing director of Hikal.

Hikal is building a new multipurpose API facility at this site to meet additional demand from its US, European and Japanese customers.

Hikal is a reliable partner to companies in the Pharmaceuticals, Agrochemicals and Fine Chemical industries and provides contract research and manufacturing services to its customers from the milligram scale to commercial tons lots.